Sunday, July 3, 2011

Finally! Canadian Government Decides to Fund CCSVI Treatment Trials…

In a surprise move, the Canadian federal government has reversed its previous decision, and decided to fund CCSVI treatment trials on MS patients (click here). Just last year, government officials decided against funding such trials, citing a lack of evidence that a clear link existed between CCSVI and MS. Now, a working group of scientific advisors, after reviewing already published research in addition to the preliminary data from the seven ongoing studies funded by the MS societies of Canada and the USA, has concluded that there is enough evidence of a relationship between the vascular abnormalities collectively known as CCSVI and Multiple Sclerosis to warrant federally funded treatment trials (click here).

This is extremely welcome news to MS patients worldwide. Although treatment trials won't answer many of the scientific and medical questions surrounding the CCSVI hypothesis, such trials will determine whether catheter venoplasty, when used to open blocked veins and improve impeded bloodflow through the central nervous system of MS patients, results in an improvement of symptoms and/or a slowed progression of the disease. While academic questions such as cause and effect ultimately must and will be answered, the most pressing issue for MS patients themselves is whether or not getting treatment for CCSVI will improve their symptoms and lessen the long-term impact their potentially crippling disease.

What's of primary importance now that a mandate has been given to commence treatment trials is the design of those trials and exactly which treatment protocols will be used on the patients enrolled in them. Over the last 18 months we've learned that treating CCSVI is far less simple than was originally thought, and the physicians most experienced in the treatment of CCSVI are in unanimous agreement that the learning curve involved with perfecting the technique is steep, and the methodologies used are still a work in progress. The fact is that many of the treating physicians use quite disparate treatment protocols, and there is no clear consensus on best practices and a standardization of treatment methodology.

As CCSVI treatment has thus far been unavailable in Canada, there is an absence of Canadian physicians experienced in the treatment procedure. I trust that the scientists involved in the Canadian trials are fully aware of such issues, and that the physicians who will be performing the treatment procedures will undergo training at the hands of the experienced physicians outside of Canada who have been blazing the trail in performing what is still an experimental procedure. It's vital that these trial procedures be done using the latest and most effective techniques, as sub-optimal procedures will lead to sub-optimal results, which would be disastrous for the advancement of the science, and could easily lead to false conclusions about the effectiveness of treatment.

I would expect that the Canadian trials will not only demonstrate whether CCSVI treatment is effective, but, if it is, which symptoms are most impacted by improving venous blood flow, and which patient populations stand to most benefit from CCSVI treatment. MS is an extremely heterogeneous disease, with no two patients experiencing the malady quite the same way. A recent study (click here) by a CCSVI treatment practice in Poland found that patients most likely to benefit from CCSVI treatment are younger females (under the age of 30) with Relapsing Remitting Multiple Sclerosis, who have had the disease for relatively short amount of time and have not yet experienced severe mobility issues. Keeping in mind that the study was based on a relatively small sample size (47 patients), and the long-term effects of successful CCSVI treatment are still unknown, such data does make some sense in the context of what is known about MS pathophysiology, especially once the disease moves from its relapsing remitting form into its progressive stages.

Recent evidence has provided tantalizing clues that suggest that the progressive stages of the disease may be driven by an abnormal immune response contained entirely within the central nervous system, in a sense approximating a rogue immune system that operates separate and apart from the systemic immune system at work in the rest of the body (I'll blog about this in the near future). The implications of these findings, if correct, are profound, and would suggest that once the disease enters its progressive stages, treatments that are effective in RRMS, even CCSVI, may be rendered useless, as they do nothing to address an aberrant immune response that is contained entirely behind the blood brain barrier, operating independently and completely unto itself.

Be that as it may, the MS community on the whole should loudly applaud the Canadian government for taking the bold if belated step of federally funding vitally important CCSVI treatment trials. At the very least, such trials will pry scientific attention away from its current togmatic insistence that MS is strictly an autoimmune disease confined only to the central nervous system, and see it as a systemic problem with physical implications reaching beyond the brain and spinal cord. For far too long the autoimmune model of the disease has ruled the day, generating billions of dollars of profit as it turned the treatment of Multiple Sclerosis a hugely lucrative business, while at the same time generating tangible but limited benefits to patients suffering from the disease. Let these Canadian trials be a huge step towards a new understanding of the MS, one that will lead to its final eradication and an end to the suffering of millions of patients worldwide.

12 comments:

At least this is a start and I think we do need clinical trials to answer a lot of questions but if angioplasty is "dangerous" then why is it okay for so many other conditions? If people have problems with blood flow and have symptoms that may be improved by correcting the blood flow then the blood flow should be corrected--people with MS should not be an exception to this--ANGIOPLASTY FOR ALL--OR NONE!

The government provided good leadership here. With this news and with me working for a company that has a private, 6 suite opperating room facility with 72 other beds, BRAND NEW, and available now, how can we get this procedures approved for this facility. The missing piece is a practitioner or team to bring to the table. Got any ideas?

The decision to launch Phase 1-2 clinical trials in Canada is a step in the right direction; however, we need treatment in Canada Now. No other angioplasty has had to meet such high standards as ccsvi angio. Phase 1-2 trials are a simple review of the safety and potential efficacy of the treatment. They are much smaller than random trials (Phase 3) and lead to no proof that any positive results are not due to placebo effect or some other unknown third factor. As such these trials will be duplicating other trials which have already been done in other countries while wasting time and dollars. While these trials are going on we will still need to leave our country for treatment, and we shouldn't have to do that! Give us treatment and then study the results.

Although politically a brilliant move that takes pressure off the government by apparently caving in to all those who have limited their demands to a call for clinical trials, we need also to be aware that it is standard practice for the medical establishment to bungle the Phase 1-2 trials for treatments they don't believe in, and given the level of expertise of Canadian clinicians, there is a real danger they will do that. Then they could claim that the treatment was being rejected because of failure of Phase 1-2 trials.

We must keep the pressure on to make the treatment available in Canada under public health insurance regardless of these trials and the best way to keep this pressure up is to press forward with ligitation under the Canadian Charter of Rights and Freedoms. Such litigation is still the objective of the Angioplasty For All (AFA) organization although raising funds continues to be a problem because AFA cannot accept charitable donations (it is illegal in Canada for a charitable organization to contribute to a litigation).

Let's hope that this is reflected world-wide, in Australia as well as Canada and elsewhere. The International Interventionist Radiologists conference in Chicago in April (?) said that angioplasty is a safe procedure for people with MS, though of course they couldn't comment on it's efficacy. There are trials underway here in Australia, and some IR specialists are offering CCSVI in private hospitals (approx. A$8,000 with Medicare refund of approx. A$1,500). This is still very much "patient-driven" at this point - most neurologists & MS Aust. do not approve of CCSVI, and tell people with MS to "save their money"!

Many are pointing their fingers at the politicians who in most case I'd agree are the problem but I wonder if in this case it's not the medical community here in Canada that has been dragging their feet. Look at what has happened in Saskatchewan. The government got behind doing clinical trials offering 5 million dollars and only one proposal was submitted that didn't meet the criteria. Now what is that all about?-Roseanna

Marc, do you have any idea of how many patients in the AMEDS-"Study" you linked actually benefited from the treatment? 47 pwMS were treated, the rest is percentages. Sounds like sham-science to me.Am looking forward to your upcomming blog about the self containing immune system, that sounds promising.Cheers, Abe

Lori-you're certainly correct in that we definitely need clinical trials. However, equating the CCSVI treatment procedure with standard angioplasty is not quite accurate. The procedure done to relieve CCSVI is venoplasty, performed on the veins. Angioplasty is performed on the arteries. This is not just a semantic difference, the two types of blood vessels have extremely different properties. All of the equipment and techniques presently used to treat CCSVI were originally designed and developed for use on arteries. While the CCSVI venoplasty treatment has proven to be safe, it is still an experimental procedure (and is usually stated as such by the doctors performing it), and there has been no standardization of optimum practices and techniques. Different doctors are using different treatment modalities, and far too many patients are experiencing restenosis relatively soon after undergoing the procedure. As many patients are paying for the procedure out-of-pocket, this is indeed a very problematic situation. Furthermore, many patients do not see benefit from the procedure, and clinical trials will be important not only in proving the procedure effective, but in detailing which subgroups of patients it's most effective on. We are just the tip of the iceberg when it comes to the study and treatment of CCSVI. Patients must keep that in the forefront of their minds.

Grant-I'm afraid you'll have to wait until the government trials prove effective, and the technique is approved for use throughout Canada. For now, the only way patients will be able to undergo the procedure in Canada will be to sign up for clinical trials.

plillies-please see my answer to Lori, above. The government is following standard protocol for clinical trials, and the procedure being used is not angioplasty, but venoplasty, a technique that most interventional radiologists have little experience with. I've spoken personally to quite a few of the US physicians doing the procedure, and they all emphasize that there is a very steep learning curve involved with getting this procedure right. Even so, the procedure is still being refined and reinvented, and procedures done six months ago differ significantly from those done today. We're all anxious to see this ball rolling. As for duplicating trials that have already been done in other countries, in fact there have been very few CCSVI treatment trials done, although a few small ones are underway. We are very much on a journey of discovery.

Jackie-I join you in your standing ovation…

Kaye-the question isn't really the safety of the procedure, but the efficacy. Unfortunately, though many thousands of patients have been treated for CCSVI, almost no effort has been made to track their outcomes, a serious failure that has certainly impacted the speed with which the procedure will be adopted. It's been estimated that upwards of 15,000 patients have undergone treatment, but we have outcome accounts of only a few hundred, at most. And those accounts come from the patients themselves, there's been no verification by independent medical authorities. Self-reported outcomes are notoriously inaccurate, as patients with positive stories are much more likely to relate them than those who have had a negative experience.

Anonymous-situation in Saskatchewan is indeed mysterious, but could be a reflection of the fact that many interventionalists are reticent about starting clinical trials until a standard protocol for the procedure has been nailed down. There is the real danger the trials done using immature techniques will yield suboptimal results, which would be disastrous.

Nicole-you are right to be excited, in a short 18 months CCSVI has gone from being relatively unknown to capturing worldwide attention, driven largely by the power of patients using the Internet to exchange information. This massive wave of informed patients is significantly altering the doctor-patient relationship, and shaking the very foundations of how medicine is practiced.

Abe-yes, the AMEDS study was small, but so far it's the only study released detailing patient outcomes. I don't expect the data to be the be-all and end-all on CCSVI Efficacy, but it at least gives us a glimpse as to its possible direction. Keep in mind, the original Zamboni research that got this whole thing started included only 65 patients…

Marc, this AMEDS paper does not provide the most important information of all - they tell us they treated 47 people but they don't tell how many of these patients actually benefited. Could have been 10/47, 20/47, 40 out of 47. - Sham science.;) Abe

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Regretfully, due to the high volume of e-mail received and the realities of living with progressive MS, I'll no longer be able to respond to all e-mails sent. I do read each note, and will do my best to answer as many messages as I can.

About Me

I'm Marc, a 53-year-old male, living in New York City with my lovely and wonderful wife Karen. Diagnosed with Primary Progressive Multiple Sclerosis in March of 2003, I now require a wheelchair to get around the city. I like to drive the wheelchair at full speed, thus the moniker "Wheelchair Kamikaze". I've managed to rig a camera to my chair, so I'm able to take videos and still photos from the unique vantage point of a wheelchair, which I intend to post here.
Before getting sick, I was the Director of DVD Production for one of the major international music companies. Yes, I was once a member of the Evil Empire...
Prior to my enlistment in the Evil Empire, I worked as a video producer and editor.
I grew up in New York City, and spent the 1980s in Boston (college and postcollege rock 'n roll craziness). During the 1990s, I lived in South Florida, until I woke up one morning and realized I was living in South Florida, came to my senses, and moved back to New York.
I hope you like my blog...